The embodiments described herein relate generally to a medical device, and more particularly to a medicament delivery device, and/or a simulated medicament delivery device having wireless connectivity and/or the capability to detect a delivery event. The embodiments described herein also relate to devices for interacting with and/or monitoring (e.g., wirelessly) with such medicament delivery devices and/or simulated medicament delivery devices via a wireless communication module.
Exposure to certain substances, such as, for example, peanuts, shellfish, bee venom, certain drugs, toxins, and the like, can cause allergic reactions in some individuals. Such allergic reactions can, at times, lead to anaphylactic shock, which can cause a sharp drop in blood pressure, hives, and/or severe airway constriction. Accordingly, responding rapidly to mitigate the effects from such exposures can prevent injury and/or death. For example, in certain situations, an injection of epinephrine (i.e., adrenaline) can provide substantial and/or complete relief from the allergic reaction. In other situations, for example, an injection of an antidote to a toxin can greatly reduce and/or eliminate the harm potentially caused by the exposure. Because emergency medical facilities may not be available when an individual is suffering from an allergic reaction, some individuals carry a medicament delivery device, such as, for example, an auto-injector, to rapidly self-administer a medicament in response to an allergic reaction.
As another example, naloxone is a medicament that prevents and/or reverses the life-threatening breathing effects of opioids. Known formulations of naloxone can be used, for example, to treat respiratory depression and other indications that result from opioid toxicity. For example, known formulations for naloxone can be used to reverse and/or mitigate the effects of an overdose of a drug containing opioids, such as, for example, prescription opioids like oxycodone or illicit opiates like heroin. In such situations, it is desirable to deliver the naloxone formulation quickly and in a manner that will produce a rapid onset of action. Known methods for delivering naloxone intranasally or via injection, however, often involve completing a series of operations that, if not done properly, can limit the effectiveness of the naloxone formulation. Moreover, because naloxone is often administered during an emergency situation, even experienced and/or trained users may be subject to confusion and/or panic, thereby compromising the delivery of the naloxone formulation.
As yet another example, glucagon is a medicament that is administered to treat patients suffering from hypoglycemia. In certain situations, the onset of hypoglycemia can cause the patient to lose motor coordination and/or lose consciousness. Thus, glucagon is often administered by a care-giver during an emergency situation.
In the above-identified examples, the individual requiring the medicament may be inexperienced and/or may infrequently require medical intervention (e.g., in the case of a naloxone delivery device), and thus may be forget to carry the medicament delivery device and/or forget how to use the delivery device. For example, to actuate some known auto-injectors, the user may be required to execute a series of operations. For example, to actuate some known auto-injectors, the user must remove a protective cap, remove a locking device, place the auto-injector in a proper position against the body and then press a button to actuate the auto-injector. Failure to complete these operations properly can result in an incomplete injection and/or injection into an undesired location of the body. If the medicament delivery device is not available or if the individual is unable to properly operate the medicament delivery device, important medical aid may not be properly delivered.
The likelihood of improper use of known medicament delivery devices can be compounded by the nature of the user and/or the circumstances under which such devices are used. For example, many users are not trained medical professionals and may have never been trained in the operation of such devices. Moreover, in certain situations, the user may not be the patient, or primary care-giver, and may therefore have no experience with the medicament delivery device. Similarly, because some known medicament delivery devices are configured to be used relatively infrequently in response to an allergic reaction or other medical emergency, even those users familiar with a device and/or who have been trained may not be well practiced at operating the device. Finally, such devices are often used during an emergency situation, during which even experienced and/or trained users may be subject to confusion, panic, and/or the physiological effects of the condition requiring treatment.
Additionally, or alternatively, the individual requiring the medicament may be incapacitated and unable to inform bystanders of the nature of the medical emergency, that a medicament delivery device is available, and/or how to use the medicament delivery device. If bystanders remain unaware of the availability and location of the medicament delivery device, or are unable to administer the medicament, important medical aid may not be delivered. To enhance the likelihood of proper use, some known medicament delivery devices include printed instructions to inform the user of the steps required to properly deliver the medicament. Such printed instructions, however, can be inadequate for the class of users and/or the situations described above. Moreover, because some known medicament delivery devices, such as, for example, auto-injectors, pen injectors, nasal delivery systems, wearable injectors or bolus pumps, transdermal delivery systems, inhalers or the like, can be compact, such printed instructions may be too small to read and comprehend during a situation requiring the need for immediate and accurate administration.
Furthermore, some known medicament delivery devices, such as, for example, auto-injectors, pen injectors, inhalers, nasal delivery systems, and/or simulated medicament delivery devices are configured to be carried with the user. Although such devices may improve the likelihood of compliance, such portable devices can exacerbate the shortcomings described above (e.g., inadequate instructions for use). Additionally, because such portable devices are small, there is an increased likelihood that such devices will be forgotten and/or misplaced. Moreover, the cost and size constraints of known devices prevents the inclusion of more detailed features to address the shortcomings described herein. As one example, such portable medicament delivery devices may have limited space for electronics. For example, unlike stationary devices, such as infusion pumps and the like, compact medicament delivery devices may have insufficient space for full-scale computational devices, such as general purpose processors, large form-factor printed circuit boards, and the like.
In addition to the issues relating to improper use of medicament delivery devices, monitoring the patient's compliance with known medicament delivery devices can also be problematic. For example, many children carry an auto-injector to deliver epinephrine in the event of an allergic reaction. Known epinephrine auto-injectors, however, do not provide robust mechanisms (or communication systems) for alerting a parent or caregiver when the child has enabled and/or used the auto-injector. For example, some known systems produce a notification when an auto-injector is removed from a case. Although this information can be helpful, it does not provide any confirmation of actual use of the device (i.e., delivery of the medicament). Additionally, simply providing an alert upon opening a container and/or removing an auto-injector can result numerous “false positives” when a user simply opens the container and/or removes the device in a situation unrelated to an actual emergency.
Moreover, known auto-injectors do not provide a suitable mechanism (or communication systems) for alerting the parent or caregiver when the child is not carrying (or within a suitable range of) the auto-injector or provide associated information related to ensuring the device is kept on or with a user at all times. For example, although some known systems produce a notification when an auto-injector is not within a predetermined distance from the user's phone, such known systems do not accommodate different usage patterns for different devices that may be owned by the user. For example, know compliance tracking systems do not differentiate between a device that is typically carried with the user and a device that is stored at a predetermined location (e.g., an auto-injector maintained at school or work).
Some known treatment regimens include multiple doses of a medicament that must be administered in a timely fashion and/or in a particular order to ensure effectiveness, especially in more chronic diseases (e.g., insulin for diabetes, certain biologic therapies for inflammatory conditions or certain vaccination regimens). Thus, in addition to alerting a caregiver in an emergency situation, monitoring the patient's adherence to a medication regimen is an important aspect in ensuring that the treatment method will be both safe and effective. Some known medicament delivery systems include a medicament delivery device and an accompanying electronic system to assist the user in setting the proper dosage and/or maintaining a compliance log. Such known medicament delivery systems and the accompanying electronic systems can be large and therefore not conveniently carried by the user. Such known medicament delivery systems and the accompanying electronic systems can also be complicated to use and/or expensive to manufacture.
In addition, an extended shelf life may be desirable for some medicament delivery devices, such as devices intended to be carried by a user on a daily basis. For example, an auto-injector intended to be carried by a user on a daily basis may be expected to work after weeks, months, or years without user maintenance. As another example, known emergency-use auto-injectors are single-use devices that are expected to be carried for years before a potential use. The disposable nature and/or extended shelf-life of such devices can further exacerbate the shortcomings described above. For example, the electronics of known stationary devices, particularly known devices having electronic communication means (e.g., for compliance tracking), may not be efficient enough to provide sufficiently long battery life for use in a portable, extended shelf life device. Furthermore, efficient power management may be desirable to extend the useful life of a medicament delivery device, particularly for a device having limited battery capacity, limited or no user replaceable batteries, and/or limited or no charging capacity.
As another way to enhance the likelihood of proper use, some known medicament delivery devices are associated with simulated medicament delivery devices (e.g., “trainers”) to provide a method for users to practice using the medicament delivery device without being exposed to the medicament and/or needles typically contained therein. Such simulated medicament delivery devices, however, can also include inadequate use instructions as described above.
Thus, a need exists for medicament delivery systems and/or devices that allow a medicament delivery device to be quickly identified and located, alert the user if the medicament delivery device is forgotten, and provide instructions that can be easily understood by a user in any type of situation. Additionally, a need exists for simulated medicament delivery systems and/or devices that can provide instructions and that can be reused multiple times. Moreover, a need exists for medicament delivery systems and/or devices that can provide compliance information associated with the use of the device and/or that can communicate electronically with other communications devices.